Staged deployment devices and methods for transcatheter heart valve delivery systems

• US 8,814,931 B2
• Filed: 08/18/2011
• Issued: 08/26/2014
• Est. Priority Date: 08/24/2010
• Status: Active Grant

• Current Assignee: St. Jude Medical Cardiology Division Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: St. Jude Medical Cardiology Division Incorporated (Abbott Laboratories Incorporated)
• Inventors: Wang, Huisun, Thomas, Ralph Joseph
• Primary Examiner(s): Dornbusch, Dianne
• Assistant Examiner(s): LYNCH, ROBERT A
• Application Number:
  US13/212,442
• Publication Number:
  US 20120078352A1
• Time in Patent Office: 1,104 Days
• Field of Search: 623/1.11, 623/1.12, 623/1.23, 623/2.11, 606/108, 606/191, 606/192, 606/194
• US Class Current: 623/2.11
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/9517 handle assemblies therefor
• CPC Class Codes: A61F 2/966 with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
• CPC Class Codes: A61F 2002/9528 for retrieval of stents
• CPC Class Codes: A61F 2002/9534 for repositioning of stents

Abstract

A delivery device for a collapsible heart valve includes an operating handle, including a frame defining a movement space therein, a carriage assembly moveable within the movement space, and a first resheathing lock having a locked position and an unlocked position. The delivery device further includes a catheter assembly, including a first shaft around which a valve-receiving compartment is defined, the first shaft being fixedly connected to one of the frame or the carriage assembly, and a distal sheath operatively connected to the carriage assembly. The distal sheath is moveable between a closed condition adapted to maintain the valve in the compartment and an open condition adapted to fully deploy the valve. With the resheathing lock in the locked position, the distal sheath is unable to move to the open condition to fully deploy the valve.

Claims

1. A delivery device for a collapsible prosthetic heart valve, the delivery device comprising:

an operating handle, including;

a frame defining a movement space therein;

a carriage assembly moveable in a longitudinal direction within the movement space; and

a first resheathing lock having a locked position and an unlocked position, the first resheathing lock in the locked position limiting movement of the carriage assembly in the longitudinal direction to a first intermediate position in the movement space, and the first resheathing lock in the unlocked position permitting movement of the carriage assembly in the longitudinal direction beyond the first intermediate position in the movement space; and

a catheter assembly, including;

a first shaft around which a compartment is defined, the first shaft being fixedly connected to one of the frame or the carriage assembly, the compartment being adapted to receive the valve in an assembled condition; and

a distal sheath operatively connected to the carriage assembly, the distal sheath being moveable between a closed condition adapted to maintain the valve in the assembled condition and an open condition adapted to fully deploy the valve,

wherein movement of the carriage assembly to the first intermediate position moves the distal sheath to a condition between the closed condition and the open condition so that the valve is not fully deployed, and

wherein the first shaft is fixedly connected to the carriage assembly, and the catheter assembly further includes an outer shaft connecting the frame to the compartment and at least partially surrounding the first shaft.

2. The delivery device of claim 1, wherein the operating handle further includes a deployment lock moveable between a locked position and an unlocked position, the deployment lock in the locked position preventing movement of the carriage assembly in the longitudinal direction within the movement space, the deployment lock in the unlocked position permitting movement of the carriage assembly in the longitudinal direction within the movement space.

3. The delivery device of claim 1, wherein the carriage assembly includes a threaded rod and the operating handle further includes a deployment actuator threadedly engaged with the threaded rod such that rotation of the deployment actuator moves the carriage assembly in the longitudinal direction in the movement space.

4. The delivery device of claim 1, wherein the compartment defines a first length and the first intermediate position in the movement space corresponds to a travel distance of the carriage assembly, the travel distance being less than the first length.

5. The delivery device of claim 4, wherein the collapsible prosthetic heart valve defines a second length and the travel distance is about 80% to about 90% of the second length.

6. The delivery device of claim 4, wherein the collapsible prosthetic heart valve defines a second length and the travel distance is about 80% to about 90% of the second length.

7. The delivery device of claim 1, wherein the operating handle further includes a second resheathing lock moveable between a locked position and an unlocked position, the second resheathing lock in the locked position limiting movement of the carriage assembly in the longitudinal direction to a second intermediate position in the movement space, the second resheathing lock in the unlocked position permitting movement of the carriage assembly in the longitudinal direction beyond the second intermediate position.

8. The delivery device of claim 7, wherein the collapsible prosthetic heart valve defines a length, the second intermediate position defines a first travel distance, and the first intermediate position defines a second travel distance, the first travel distance being about 40% to about 60% of the length and the second travel distance being about 80% to about 90% of the length.

9. The delivery device of claim 7, wherein the collapsible prosthetic heart valve defines a length, the second intermediate position defines a first travel distance, and the first intermediate position defines a second travel distance, the first travel distance being about 40% to about 60% of the length and the second travel distance being about 80% to about 90% of the length.

10. A delivery device for a collapsible prosthetic heart valve, the delivery device comprising:

an operating handle, including;

a frame defining a movement space therein;

a carriage assembly moveable in a longitudinal direction within the movement space; and

a first resheathing lock having a locked position and an unlocked position, the first resheathing lock in the locked position limiting movement of the carriage assembly in the longitudinal direction to a first intermediate position in the movement space, and the first resheathing lock in the unlocked position permitting movement of the carriage assembly in the longitudinal direction beyond the first intermediate position in the movement space; and

a catheter assembly, including;

a first shaft around which a compartment is defined, the first shaft being fixedly connected to one of the frame or the carriage assembly, the compartment being adapted to receive the valve in an assembled condition; and

a distal sheath operatively connected to the carriage assembly, the distal sheath being moveable between a closed condition adapted to maintain the valve in the assembled condition and an open condition adapted to fully deploy the valve,

wherein movement of the carriage assembly to the first intermediate position moves the distal sheath to a condition between the closed condition and the open condition so that the valve is not fully deployed, and

wherein the frame includes a slot and the first resheathing lock includes a retractable locking member that is engaged in the slot when the first resheathing lock is in the locked position, an end of the slot defining the first intermediate position.

11. The delivery device of claim 10, wherein the first shaft is fixedly connected to the frame, the catheter assembly further including an outer shaft connecting the carriage assembly to the distal sheath and at least partially surrounding the first shaft.

12. The delivery device of claim 10, wherein the operating handle further includes a deployment lock moveable between a locked position and an unlocked position, the deployment lock in the locked position preventing movement of the carriage assembly in the longitudinal direction within the movement space, the deployment lock in the unlocked position permitting movement of the carriage assembly in the longitudinal direction within the movement space.

13. The delivery device of claim 10, wherein the carriage assembly includes a threaded rod and the operating handle further includes a deployment actuator threadedly engaged with the threaded rod such that rotation of the deployment actuator moves the carriage assembly in the longitudinal direction in the movement space.

14. The delivery device of claim 10, wherein the compartment defines a first length and the first intermediate position in the movement space corresponds to a travel distance of the carriage assembly, the travel distance being less than the first length.

15. The delivery device of claim 10, wherein the operating handle further includes a second resheathing lock moveable between a locked position and an unlocked position, the second resheathing lock in the locked position limiting movement of the carriage assembly in the longitudinal direction to a second intermediate position in the movement space, the second resheathing lock in the unlocked position permitting movement of the carriage assembly in the longitudinal direction beyond the second intermediate position.

16. A system for delivery of a collapsible prosthetic heart valve, the system comprising:

a collapsible prosthetic heart valve;

an operating handle, including;

a frame defining a first longitudinal end and a second longitudinal end spaced apart in a longitudinal direction of the operating handle, and a movement space located between the first and second longitudinal ends;

a carriage assembly having a first longitudinal end and a second longitudinal end spaced apart in the longitudinal direction, the carriage assembly moveable in the longitudinal direction within the movement space, the first and second longitudinal ends of the carriage assembly located within the movement space; and

a first resheathing lock having a locked position and an unlocked position, the resheathing lock in the locked position limiting movement of the carriage assembly in the longitudinal direction to a first intermediate position in the movement space, and the first resheathing lock in the unlocked position permitting movement of the carriage assembly in the longitudinal direction beyond the first intermediate position in the movement space; and

a catheter assembly, including;

a first shaft around which a compartment is defined, the first shaft being fixedly connected to one of the frame or the carriage assembly, the valve being mounted in the compartment in an assembled condition; and

a distal sheath operatively connected to the carriage assembly, the distal sheath being moveable between a closed condition adapted to maintain the valve in the assembled condition and an open condition adapted to fully deploy the valve,

wherein movement of the carriage assembly to the first intermediate position moves the distal sheath to a condition between the closed condition and the open condition so that the valve is not fully deployed, and

wherein the first shaft is fixedly connected to the carriage assembly, and the catheter assembly further includes an outer shaft connecting the frame to the compartment and at least partially surrounding the first shaft.

17. The system of claim 16, wherein the collapsible prosthetic heart valve defines a length and the first intermediate position in the movement space corresponds to a travel distance of the carriage assembly, the travel distance being about 80% to about 90% of the length.

18. The system of claim 16, wherein the operating handle further includes a second resheathing lock moveable between a locked position and an unlocked position, the second resheathing lock in the locked position limiting movement of the carriage assembly in the longitudinal direction to a second intermediate position in the movement space, the second resheathing lock in the unlocked position permitting movement of the carriage assembly in the longitudinal direction beyond the second intermediate position.

19. The system of claim 18, wherein the collapsible prosthetic heart valve defines a length, the second intermediate position defines a first travel distance, and the first intermediate position defines a second travel distance, the first travel distance being about 40% to about 60% of the length and the second travel distance being about 80% to about 90% of the length.